IMMUNEONCO-B(01541): The PAH trial of IMC-003 has completed the first patient dosing, and enrollment for the SAD and MAD dose groups is complete.

IMMUNEONCO-B (01541) announced that IMC-003/IMM72 (IMC-003, a type of Activin Receptor IIA-Fc fusion protein independently developed by the companys subsidiary Yimingkaier Biopharmaceutical Technology (Shanghai) Co., Ltd.) has achieved two significant clinical milestones. The Phase Ib/IIa clinical trial conducted in patients with pulmonary arterial hypertension (PAH) has completed the enrollment and dosing of the first subject, marking the official advancement of IMC-003s clinical development into the patient validation stage. The Phase I single ascending dose (SAD) study conducted in postmenopausal healthy women has completed the enrollment and safety observation period assessment for all dose groups (seven dose groups). IMC-003 showed good overall tolerability at the 8 mg/kg dose level, with no dose-limiting toxicities (DLTs) reported. The majority of adverse events (AEs) related to the investigational drug (IMC-003 or placebo) were grade 1, and no grade 3 or higher AEs related to treatment were reported. In the Phase I multiple ascending dose (MAD) study conducted in postmenopausal healthy women, the fourth dose group (2 mg/kg) successfully completed enrollment of all eight subjects on August 17, 2026. At this point, all dose groups designed in the protocol have completed enrollment. Early safety data is encouraging: all AEs in the MAD phase were grade 1 or 2, with no reports of grade 2 or higher hemoglobin elevation AEs, and no DLT events occurred in the first three dose groups. The fourth dose group has not yet reached its designated safety observation period evaluation endpoint.